510(k) Report

Devices descending from K760093

6 later devices reach Catheter, Silicone Foley (Bardex) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041983Option-VM Urinary Catheter/Adpater, Models MV39016, MVA39016Opticon Medical200411
+1K033830Option-VF Urinary Catheter with Adaptor, Model FVA14218; Option-V Continuous Drainage…Opticon Medical, Inc.20042—
+1K023090Option-VF Urinary Catheter, FV14218Opticon Medical, Inc.200331
+1K961697Opticon Female Urinary Incontinence Catheter for Continuous DrainageMedical Device Intl., Inc.19965—
+2K062240CareventChief Medical, LLC20060—
+2K970716Opticon Direct Male Urinary Catheter for Continuous DrainageOpticon Medical, Inc.19970—